Lawmaker seeks data from J&J on FDA stent warning
- Reuters
08/14/2007 - Johnson & Johnson said on Tuesday the chairman of a U.S. House of Representatives committee asked for records related to a 2004 warning letter from U.S. regulators on its drug-eluting Cypher stent.
U.S. Rep. John Dingell, chairman of the House Committee on Energy and Commerce, asked for J&J's documents related to the April 2004 warning letter as part of an investigation into the U.S. Food and Drug Administration's ability to protect the public from risks linked to the products it regulates.
A spokesman for J&J's Cordis unit said the company will cooperate with the committee's request.
FDA in June 2007 lifted the warning letter, which concerned manufacturing practices and quality systems used in making the Cypher device to treat clogged heart arteries.
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